GSO ISO/TS 13004:2021
Gulf Standard
Current Edition
·
Approved on
01 July 2021
·
Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
GSO ISO/TS 13004:2021 Files
No files are available for this standard right now!
GSO ISO/TS 13004:2021 Scope
ISO/TS 13004:2013 describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation sterilization of health care products. ISO/TS 13004:2013 also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
Best Sellers From Health Sector
BH GSO 1943:2022
GSO 1943:2021
Bahraini Technical Regulation
Cosmetic Products – Safety Requirements of Cosmetics and Personal Care Products
GSO 1943:2021
Gulf Technical Regulation
Cosmetic Products – Safety Requirements of Cosmetics and Personal Care Products
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
BH GSO 2017:2023
GSO 2017:2023
Bahraini Standard
Personal Care and Baby Wet Wipes
Recently Published from Health Sector
GSO ISO 11978:2024
ISO 11978:2017
Gulf Standard
Ophthalmic optics — Contact lenses and contact lens care products — Labelling
GSO ISO 11608-6:2024
ISO 11608-6:2022
Gulf Standard
Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems
GSO ISO 16256:2024
ISO 16256:2021
Gulf Standard
Clinical laboratory testing and in vitro diagnostic test systems — Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
GSO ISO 14708-3:2024
ISO 14708-3:2017
Gulf Standard
Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators